Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study

Type 2 Diabetes Clinical Trial

Official title:

Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381186
• Other study ID #: NWO 2200.0139
• Secondary ID: ZonMW 940-35-034
• Status: Completed
• Phase: N/A
• First received: September 25, 2006
• Last updated: November 8, 2016
• Start date: February 1999
• Est. completion date: June 2006

Study information

• Verified date: September 2006
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on general public health recommendations, on glucose tolerance, insulin resistance and metabolic cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).

Description:

Objective To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on general public health recommendations, on glucose tolerance, insulin resistance and metabolic cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).

Research design and methods 147 IGT subjects (75 male, 72 female) were randomized to the intervention group (INT) or control group (CON). 106 subjects (52 INT, 54 CON) completed 3 years of intervention. Annually, glucose, insulin and FFA concentrations were determined during fasting and after an oral glucose tolerance test, in addition to measurements of body weight, serum lipids, blood pressure and maximal aerobic capacity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• caucasion,age 40-70, mean 2hr glucose 7.8-12.5 mmol/l, mean fasting blood glucose below 7.8

Exclusion Criteria:

• known type 2 diabetes, mean 2hr glucose >12.5 mmol/l, mean fasting blood glucose > 7.8 mmol/l, chronic illness that makes 5-year survival improbable, interferes with glucose tolerance or makes participation in a lifestyle intervention impossible, medication known to interfere with glucose tolerance, participation in a vigorous exercise and/or diet program

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance
• Type 2 Diabetes

Intervention

Behavioral:
• diet- and exercise intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-hour glucose levels
Primary	insulin resistance
Secondary	adherence
Secondary	type 2 diabetes
Secondary	dietary intake change
Secondary	exercise change